In the last ten years, the overall incidence of osteoporosis and fractures related to bone fragility increased by about 30%. Such an increase is partly linked to the higher life expectancy of the population in the last 50 years. In general, osteoporosis is a global health problem: the World Health Organization considers osteoporosis as the second critical health problem, preceded only by cardiovascular diseases. Based on the estimates made by the World Health Organization, in 2050 about 6.3 million of femoral fractures can occur, about 4.6 million more than in 1990. In Italy, femoral fractures caused by osteoporosis cost to the health service (SSN) 6.8 billion euros every 5 years. Considering that femoral fractures increase within each decade both for women (28%) and men (36%), it follows an increased need of hospital stays or home care, with remarkable increase of costs to be paid by the SSN. In Italy, it is estimated that each year from 70,000 to 90,000 hospitalizations for femoral fracture occur and it is estimated that the health expenditure for direct costs amounts to 568 million Euro per year. Therefore, the use of a drug/supplement targeting the reduction of the risk of fracture, would allow a remarkable reduction of expenditure by the SSN with remarkable economic benefits, in addition to improving the quality of life of the elderly population.
Osteoporosis is a condition wherein the skeleton is subjected to a loss of bone mass and resistance, due to multiple factors such as, for example, nutritional, metabolic or pathologic factors. Thus, the skeleton is subjected to higher risk of fractures, following to the decrease in bone density and changes and/or alterations occurring at the level of the microarchitecture of the bones.
Generally, osteoporosis predisposes, as mentioned, to greater development of fractures, both traumatic and pathologic, consequently leading to a reduction in the life quality and expectancy. Furthermore, it must not be overlooked the aspect caused by the possibility of the occurrence of complications due to the fractures, if not properly treated.
A number of therapies for osteoporosis are known. For example, the supplementation of D3 vitamin is helpful both in healthy subjects to carry out preventive action, and in osteoporotic and osteopenic subjects. The two forms of D vitamin used are D2 vitamin (ergocalciferol) and D3 vitamin (cholecalciferol), orally or intramuscularly administrable.
Other known supplementary treatments, which produce a beneficial effect at the bone level, are for example the supplementation of calcium (for example calcium carbonate), magnesium (for example in the form of magnesium pidolate) and various other microelements, such as manganese, boron, strontium, silicon and zinc.
In the care of osteoporosis so called “antiresorptive” drugs, that is drugs acting by reducing or blocking the bone erosion mediated by osteoclasts and with this mechanism being able to considerably reduce pathologic fractures, are also used. Some examples of these drugs are: denosumab, alendronate, risedronate, ibandronate, neridronate, clodronate, zoledronate, calcitonin, and drugs acting on hormonal levels such as raloxifene, bazedoxifene, lasofoxifene, tibolone, TOS with estrogen-progestin, testosterone (androgens).
Another example of used drug is strontium ranelate (a strontium salt), which is the initiator of a class of drugs known as DABA (Dual Action Bone Agents), the characteristic of which is to have a dual action. In fact, strontium ranelate acts both as an antiresorptive drug and as an anabolic drug. In other words, strontium ranelate acts both by suppressing osteoclasts and, at the same time, stimulating the production and activity of the osteoblasts, thereby inducing an increase of bone mineral density (BMD).
Also drugs known as “osteoforming”, characterized by an action mechanism based on the bone reconstruction, as opposed to the so called “antiresorptive” drugs, that are limited instead to reduce the bone erosion, are used.